Zetia - Articles - Zimbio

Cholesterol Drug Zetia Doesn't Benefit Health, Trial Shows

Mon, 15 Jan 2008 02:45:00 GMT

posted by gossindia

results of a trial of Zetia, a cholesterol-lowering drug prescribed to about a million Americans, shows the drug confers no medical benefit to users.
In fact, the pace at which artery-clogging plaques formed within vessels almost doubled in patients taking Zetia (ezetimibe) along with another cholesterol-lowering drug, Zocor (simvastatin), compared to those taking Zocor alone, the study found.
The two medications -- ezetimibe plus simvastatin -- are also marketed in one prescription pill, called Vytorin. About 60 percent of U.S. patients who are taking Zetia now receive the drug as part of Vytorin.
But the new two-year trial of 720 patients sheds doubt on whether it makes any sense for people battling cholesterol to take Vytorin versus Zocor alone, experts said. The study was funded by the two companies that make Zetia, Merck and Schering-Plough.
"This wraps it up," said Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic. "That's all there is. There just isn't any evidence that adding ezetimibe to simvastatin produces any advantage."
No one is disputing that Zetia can lower levels of LDL "bad" cholesterol by 15 percent to 20 percent -- that had been shown in previous trials. However, whether that reduction led to any greater lowering of heart attack or stroke risk had remained unclear.
The new ENHANCE trial -- which involved patients with a genetic condition that causes abnormally high levels of blood cholesterol -- found no such added benefit. According to a statement released by the two drug companies Monday, researchers found no statistically significant difference in heart attacks or stroke among trial participants who took Zetia plus Zocor, a widely used cholesterol-lower drug, versus those who got Zocor alone.
The study also noted that the speed at which arteries thickened with plaque almost doubled among those on the two-drug regimen compared to those taking Zocor alone.
Safety profiles were similar for Zetia/Zocor versus Zocor alone, the team added.
"These results are very important considerations on how we treat patients with elevated cholesterol and will very likely impact the way we choose drugs to lower cholesterol and eliminate plaque," said Dr. Howard Weintraub, clinical director of the Center for the Prevention of Cardio-Vascular Disease at New York University Medical Center, New York City, and clinical associate professor at the NYU School of Medicine.
"ENHANCE found that plaque got slightly worse when the drug combination was used," Weintraub noted in a statement. "But, the real take-home message here is that getting LDL down is important, and that's not something that should be lost as a consequence of this study."
The ENHANCE study was completed in April 2006, but the results were only released Monday by Merck and Schering-Plough after continual prodding by medical professionals. According toThe New York Times, the companies had initially planned to release the findings by March 2007, but then missed several self-imposed deadlines, blaming the delay on the complexities of necessary data analysis.
Now that the results have arrived, Zetia and Vytorin should be viewed as "drugs of last resort," for patients not helped by standard statin therapy, Nissen said. Only if you can't tolerate full doses of simvastatin should you take ezetimibe, he said.
"This is one of the most widely advertised and widely used drugs out there, so it's obviously good to get these study results," Nissen added.
Another group questioned why patients should be prescribed more expensive cholesterol-lowering drugs, such as Vytorin, versus cheaper, generic statins such as Zocor.
"We already know that millions of people who take these brand drugs probably don't need to; they could be taking a less expensive generic instead. This study lends support to that cost-saving strategy for the health system and for consumers," said Steven Findlay, managing editor ofConsumer Reports Best Buy Drugs, a public information and education project of Consumers Union, publisher ofConsumer Reports.
"If there is no apparent clinical benefit, why take a drug that cost three or four times more?" Findlay said in a statement. "Most people do not need that magnitude of cholesterol reduction anyway."
Sales of Zetia and Vytorin totaled $3.7 billion in the nine months ending Sept. 30, up 33 percent from a year ago. Analysts estimate that about 70 percent of Schering-Plough's earnings depend on the drugs, theTimesnoted.
More information There's more on lowering cholesterol at the American Heart Association.

Vytorin : What's a Patient to Do?

Tue, 16 Jan 2008 04:02:00 GMT

posted by jfaye15
If you've watched the news or read the newspaper, you probably know that there is some apparent controversy about the cholesterol drug Vytorin. The results of the study nicknamed ENHANCE were just released, and the results were not as favorable as hoped. However, there is no need to panic if you're taking Vytorin; the results showed nothing harmful either.
Vytorin (ezetimibe-simvastin) is a combination drug consisting of Zetia (ezetimibe) manufactured by Schering-Plough and Zocor (simvastatin) manufactured by Merck. Vytorin is designed to lower cholesterol, particularly LDL-cholesterol, and therefore decrease cardiac risk. This has been proven and is well-documented and the results of the ENHANCE trial do not refute that. However, The ENHANCE trial set out to determine if Vytorin reduced plaque in the carotid arteries more than simvastatin alone. The manufacturers were hoping for a resounding "Yes"; instead they got a "Same" result.
So what does it REALLY mean?? Is it bad for your heart? Well, it's not good for your blood pressure if you watched the shares of Merck and Schering-Plough go down this week on results of the news. However, let me reiterate: there is no cause to panic. Vytorin is still a very effective medication for reducing cholesterol; it's just that in this study, it did not show the hoped-for results in reducing plaque build-up better than simvastatin alone.
So, the question becomes should you take the more expensive Vytorin rather than the less expensive generic simvastain? Ultimately, that is a question you and your physician should discuss and determine what is best for you, taking into consideration other risk factors and co-morbid conditions.
My PERSONAL opinion is that Vytorin still offers benefits, since it's ingredients Zocor and Zetia have different mechanisms of actions in lowering cholesterol. And usually this means that the patient has an alternative to just increasing the dose of the statin, and thereby may lessen the chance of side effects. (Again, all drugs have side effects and the individual response may vary) Also, this study was a subset of 700 patients witha rare form of hypercholesterolemia that only occurs in about 1% of the population. There are more studies due out soon which look at more that 20,000 patients. I believe that waiting for these outcomes is worthwhile and may show a more relevant picture.
The ACC, American College of Cardiolgy, has released a statement which I have included below. Hopefully, that will allay the "drama" that the media loves so much.
"The ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) trial results were released by Merck and Schering-Plough Pharmaceuticals on January 14, 2008. The results of the trial show no benefit from the combination of ezetimibe (Zetia) and simvastatin (sold together as Vytorin) over simvastatin alone in terms of affecting the rate of atherosclerosis progression.The study involved 720 patients with heterozygous familial hypercholesterolemia and showed no significant difference in the primary endpoint between patients treated with ezetimibe and simvastatin versus patients treated with simvastatin alone over a two-year period. The study was designed to prove that Vytorin could slow the growth of plaque in carotid arteries supplying the brain more than simvastatin alone. Media reports indicate that the results of the trial show no benefit from the combination of ezetimibe (Zetia) and simvastatin (sold together as Vytorin) over simvastatin alone.The American College of Cardiology recommends that major clinical decisions not be made on the basis of the ENHANCE study alone.According to the American College of Cardiology (ACC), this study deserves serious thought and follow-up. The overall incidence rates of cardiac events were nearly identical between both treatment groups, and both medicines were generally well tolerated. There should no be reason for patients to panic. The difference in IMT changes between the simvastatin group and the Vytorin group was 0.006 mm vs. 0.011 mm.Health care professionals should speak to their concerned patients using this drug. The ACC is also releasing a public statement explaining that this is not an urgent situation and patients should never stop taking any prescribed medications without first discussing the issue with their health care professional. Further research will be needed in this area to provide conclusive evidence about which lipid lowering strategy is preferred (statin alone vs. statin plus ezetimibe).Furthermore, the ACC notes that this trial is an imaging study and not a clinical-outcome study. Conclusions should not be made until the three large clinical-outcome trials are presented within the next two to three years. The ACC recommends that Zetia remain a reasonable option for patients who are currently on a high dose statin but have not reached their goal. The ACC also notes that Zetia is a reasonable option for patients who cannot tolerate statins or can only tolerate a low dose statin.Reports also indicate that the ENHANCE trial has been submitted as an abstract to be presented at the upcoming American College of Cardiology Scientific Session in March, 2008. The late-breaking clinical trial selections by the meeting co-chairs are scheduled to occur in late January.For more information on the ENHANCE trial, please visit Cardiosource at http://www.cardiosource.com/clinicaltrials/trial.asp?trialID=1640.

Welcome to our wikizine about the drug Zetia

Tue, 12 Dec 2007 17:05:43 GMT

posted by The_Zimbio_Team
Wikizines are interactive magazines that anyone can create or edit - and this one is called "Zetia". Here you can find fresh voices and respond in real time. Some members write articles about recent news and trends related to the wikizine's topic, others recount relevant personal stories or share their favorite pictures and video clips. Got an interesting idea or story to share with other members of this wikizine? Well, then put on your journalist's cap and add your own article!